Member Sign In

You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating indiv idual securities.

If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.

The company’s management expects the questions to be addressed in the first quarter of 2014. Following a successful response, the committee is expected to give its opinion in a meeting in the following month.

Endocyte had submitted an MAA seeking approval for vintafolide for platinum-resistant ovarian cancer in 2012. The company is also seeking EU approval for a folate-targeted molecular imaging agent, etarfolatide. These applications are supported by four clinical studies: a phase I study in solid tumors, two single agent and single-arm phase II studies in ovarian cancer and non-small cell lung cancer (NSCLC) and phase II PRECEDENT trial.

The applications for conditional marketing authorization were accepted by the EMA in Nov 2012, for vintafolide for the treatment of platinum-resistant ovarian cancer and etarfolatide and folic acid for patient selection.

We note that Endocyte and Merck & Co. Inc. (MRK - Free Report) had entered into a partnership in Apr 2012, wherein Endocyte granted Merck an exclusive license to develop, manufacture and commercialize vintafolide outside the U.S.

Endocyte expects interim results from phase III PROCEED study in the second quarter of 2014. Endocyte completed enrollment in the phase IIb TARGET study of vintafolide in NSCLC patients. Top-line data from the study is expected in the first quarter of 2014.

Endocyte and Merck will initiate a phase II randomized trial on vintafolide in folate receptor-positive triple negative breast cancer in the first half of 2014.

For its folate-targeted tubulysin therapeutic, EC1456, an investigational new drug application was accepted by the U.S. Food and Drug Administration (FDA) in Sep 2013. Endocyte dosed its first patient in a phase I study evaluating EC1456, for the treatment of advanced solid tumors in Dec 2013.

Resources

Client Support

Follow Us

Zacks Research is Reported On:

Yahoo

MSN

Marketwatch

Nasdaq

Forbes

Investors.com

Morningstar

Zacks Investment Research is an A+ Rated BBB Accredited Business.

Copyright 2016 Zacks Investment Research

At the center of everything we do is a strong commitment to independent research and sharing its profitable discoveries with investors. This dedication to giving investors a trading advantage led to the creation of our proven Zacks Rank stock-rating system. Since 1988 it has nearly tripled the S&P 500 with an average gain of +26% per year. These returns cover a period from 1988-2015 and were examined and attested by Baker Tilly Virchow Krause, LLP, an independent accounting firm.

Visit performance for information about the performance numbers displayed above.